Influenza Clinical Trial
Official title:
Open-Label Study of Intramuscular Inactivated Influenza A/H5N1 Vaccine in Healthy Children Aged 2 Years to 10 Years
This study may provide safety information on a flu vaccine given to children and may provide immunogenicity information to add to what was collected in a previous flu vaccine study. Participants will include 55 healthy children, ages 2-10, who participated in 04-077 and received a placebo injection instead of the flu vaccine or were incompletely immunized. The study has 2 purposes: to make sure there are no serious side effects in children and to see how the immune systems react to the vaccine. Study procedures include up to 4 study visits, up to 9 follow-up phone calls, 2 blood samples to be collected during visits 1 and 3, and up to 3 vaccine injections in the arm or thigh muscle. Parents will be given a memory aid card to record side effects, temperatures, and medications. Parents will have the option for the child to receive a 3rd dose of vaccine if offered, at month 6. This booster shot will require a 6-month visit and participation for an additional 6 months.
Status | Completed |
Enrollment | 35 |
Est. completion date | December 2007 |
Est. primary completion date | October 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 2 Years to 10 Years |
Eligibility |
Inclusion Criteria: - The subject must be male or female, aged 2 through 10 years at enrollment, and must have participated in protocol 04-077 as a placebo recipient or a subject at the UCLA site. - The subject must be in good health (and not on any chronic medications), as determined by medical history and a history-directed targeted physical examination. - Parents or guardians of the subject must be able to understand and comply with planned study procedures and be available for all study visits. - Parents or guardians of the subject must provide written consent prior to initiation of any study procedures, and subject may provide written assent as appropriate. Exclusion Criteria: - The subject must not have a known allergy to eggs or other components of the vaccine or sensitivity or allergy to latex. - The subject must not have a history of asthma or recurrent wheezing. - The subject must not be undergoing immunosuppression as a result of an underlying illness or treatment. - The subject must not have an active neoplastic disease or a history of any hematologic malignancy. - The subject must not be using oral or parenteral steroids, inhaled steroids, or other immunosuppressive or cytotoxic drugs. Note: Subjects on nasal or topical steroids will be allowed to enroll in this study. - The subject must not have a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study. - The subject must not receive any other inactivated vaccines within 2 weeks before or after any study vaccine or any other live vaccines within 4 weeks before or after any study vaccine in this study. - The subject must not have an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses (these conditions include, but are not limited to, known chronic liver disease, significant renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients). - The subject must not have a history of severe reactions following immunization with contemporary influenza virus vaccines. - The subject must not have an acute illness, including an axillary temperature greater than or equal to 100 degrees F or an oral temperature greater than or equal to 101 degrees F within 3 days prior to vaccination. - The subject must not have received an experimental vaccine or medication within 1 month prior to enrollment in this study, or expect to receive an experimental vaccine, medication, or blood product during the 13-month study period. - The subject must not have any condition that would, in the opinion of the investigator, place them at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol. - The subject must not have a history of Guillain-Barré syndrome. - The subject must not be participating concurrently in another clinical trial aside from DMID 04-077 (either in active phase or in follow-up phase). |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | University of Maryland Baltimore | Baltimore | Maryland |
United States | Saint Louis University | St. Louis | Missouri |
United States | UCLA Center For Vaccine Research | Torrance | California |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence of Solicited Adverse Events Among All Subjects | Number of subjects reporting solicited Adverse Events collected on Memory Aid for Days 0-7 post each vaccination for all subjects (systematic assessment), for any and severe severities. | Days 0-7 post each vaccination | Yes |
Primary | Occurrence of the Solicited Adverse Event of Body Aches, Solicited Only From Children Age 6-10 | Number of subjects reporting solicited Adverse Event of Body Aches, collected on Memory Aid for Days 0-7 post each vaccination for children age 6-10 only (systematic assessment), of any and severe severities. | Days 0-7 post each vaccination | Yes |
Primary | Occurrence of Unsolicited Adverse Events | Number of subjects with spontaneous reports of Adverse Events of any and severe severities. Events reported by more than 5.6% of subjects in any group are reported by MedDRA Preferred Term. | Through Day 28 after second vaccination | Yes |
Primary | Occurrence of Serious Adverse Events | Number of subjects with Serious Adverse Events during the 6 months after the first vaccination. | 6 months after the first vaccination | Yes |
Secondary | Number of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Titers of 1:40 or Greater | Number of subjects achieving serum hemagglutination inhibition antibody titer of 1:40 or greater against the influenza A/H5N1 virus after receipt of two doses of vaccine. | Day 28 after second vaccination | No |
Secondary | Geometric Mean Titer of Hemagglutination Inhibition Antibody Titers | Geometric mean titer of hemagglutination inhibition antibody titers after receipt of two doses of vaccine. | Day 28 after second vaccination | No |
Secondary | Number of Participants With a Four-fold or Greater Increase in Hemagglutination Inhibition Antibody Titers | Number of subjects with a 4-fold or greater increase, relative to baseline, in hemagglutination inhibition antibody titers after receipt of two doses of vaccine. | Day 28 after second vaccination | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05523089 -
The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults
|
Phase 2 | |
Completed |
NCT05009251 -
Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake
|
N/A | |
Completed |
NCT03282240 -
Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US
|
Phase 3 | |
Completed |
NCT00971425 -
Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1)
|
Phase 3 | |
Completed |
NCT00968539 -
Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults
|
Phase 3 | |
Completed |
NCT00968526 -
Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults
|
Phase 3 | |
Completed |
NCT05525494 -
Patient Portal Flu Vaccine Reminders (5)
|
N/A | |
Completed |
NCT04074928 -
Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects
|
Phase 3 | |
Completed |
NCT04695717 -
This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Under 18 Years Old and the Elderly Over 60 Years Old in Vietnam
|
Phase 3 | |
Completed |
NCT05012163 -
Lottery Incentive Nudges to Increase Influenza Vaccinations
|
N/A | |
Completed |
NCT03888989 -
Response to Influenza Vaccine During Pregnancy
|
Phase 1 | |
Completed |
NCT04109222 -
Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively
|
Phase 4 | |
Completed |
NCT02587221 -
Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age
|
Phase 3 | |
Completed |
NCT03453801 -
The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection
|
Phase 1 | |
Completed |
NCT01440387 -
A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older
|
Phase 3 | |
Terminated |
NCT01195779 -
Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children
|
Phase 2 | |
Completed |
NCT03321968 -
Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults
|
Phase 3 | |
Completed |
NCT00972517 -
Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children
|
Phase 3 | |
Completed |
NCT04570904 -
Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness
|
||
Recruiting |
NCT03331991 -
Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel
|
N/A |